|Event Name||Event Description||Event Dates||Event Location|
Evolution Summit Spring 2019 (Invitation only event)
The Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
Date: February 24–26 2019
Session Title: The A-Z of Risk-Based Monitoring (RBM): Strategies for the Future
Session Information: As the clinical trials industry continuously evolves, novel strategies must be implemented in an effort to operate efficiently and ultimately accelerate drugs to market. A more centralized, risk-based approach to site monitoring has presented itself as one viable method of reducing costs. Although RBM has been buzzing in the industry for quite some time, its adaptation has been slow. This presentation will shed light on:
Session Participation: Linda B. Sullivan, Executive Director, Metrics Champion Consortium
Rancho Mirage, CA
SCOPE – Summit for Clinical Ops Executives 2019
Date: Tuesday, February 19, 2019 (4:15–5:00 PM)
Interactive Breakout Discussions:
Participation: Moderator – Linda B. Sullivan, Executive Director, Metrics Champion Consortium
Date: Wednesday, February 20, 2019 (8:55 AM)
Track: Mastering an Outsourcing Strategy
Panel Discussion: Ensuring Harmony between All Stakeholders – Sponsor, CRO, and Site – When Site Sourcing
Topics to be discussed: Working with stakeholders on setting appropriate site budgets, site contracting, site identification, selection of sites, and site oversight/ management
Moderator: Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.
Panelists: Jennifer Trevor, Ph.D., Sr. Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma
ICH E6 GCP Interactive Workshop – How to Build A Sponsor Risk Management Program
Presented by FDAnews and Technical Resources International Inc.
For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.
Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
Clinical Trial Risk and Performance Management Summit
A Metrics Champion Consortium/CenterWatch Event
Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. Our keynote speaker will be Ken Getz, Associate Professor and Director, CSDD, Tufts University and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Linda and Ken and our roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:
Institute of Clinical Research—Project Management Forum
Thursday October 19, 2018 • Farnborough in the UK
Presenter: Keith Dorricott
Presentation Topic: “Risk Assessment in the era of ICH E6 (R2): Building on the TransCelerate Risk Assessment and Categorization Tool (RACT)”
Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)
Mark your calendar for Thursday, Oct. 18, when Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2).
During 60 fast-paced minutes Linda and Keith will:
DIA 2018 Annual Meeting
Date and Time: June 26, 2018
Session Title: The Risk Assessment is Done – Now What?
Linda B. Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM LLC
Nurcan Coskun, Ph.D.
Global Risk Based Monitoring Program and Technology Solutions Manager | MC2
Director, Dorricott Metrics & Process Improvement Ltd,
Olgica Klindworth, MS Analytics
Associate Director, Data Analytics
Pharmaceutical Industry Project Management Group Meeting
Date and Time: June 11, 2018
Session Title: Pharmaceutical Industry Project Management Group Meeting
Workshop Title: Defining Metrics that Answer the Questions That Matter
Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, MCC Ambassador
Comprehend Systems Webinar
Date and Time: May 23, 2018 1-2 pm EDT
Session Title: Comprehend Systems Webinar
Session Description: “Best Practices in Defining and Aggregating Study Data for Oversight”
Linda B. Sullivan, METRICS CHAMPION CONSORTIUM
Clinical Trial Innovation Summit
Date and Time: May 7, 2018 8:30 am EDT
Session Title: Mastering Risk-Based Monitoring – Part 1
Session Description: Updating Your Risk Evaluation Process to Support Centralized Monitoring and Risk-based Monitoring
Linda B. Sullivan, METRICS CHAMPION CONSORTIUM